BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 1 PC SHELL 38MMX52MM

    MDR report key: 3813422 · Received May 15, 2014

    Report

    Report Number
    0001825034-2014-04113
    Event Type
    Injury
    Date Received
    May 15, 2014
    Report Date
    July 15, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, "MATERIAL SENSITIVITY REACTIONS." NUMBER 6 STATES, "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." NUMBER 8 STATES, "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY MAY ALSO CONTRIBUTE TO THESE CONDITIONS." NUMBER 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." NUMBER 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 1 OF 5 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-04113 / 04115 & 04117 / 04118).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006 AND A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. PATIENT'S LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, BONE/TISSUE DAMAGE, DIFFICULTY WALKING, DISLOCATION, ELEVATED METAL ION LEVELS AND METALLOSIS. SUBSEQUENTLY, PATIENT UNDERWENT RIGHT HIP REVISION PROCEDURES ON (B)(6) 2008 AND (B)(6) 2009. THE MODULAR HEAD WAS REMOVED AND REPLACED DURING THE (B)(6) 2008 REVISION PROCEDURE. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED IN THE (B)(6) 2009 REVISION PROCEDURE. THERE HAS BEEN NO REPORTED LEFT HIP REVISION PROCEDURE TO DATE. ADDITIONAL INFORMATION PROVIDED IN PATIENT MEDICAL RECORDS INDICATES RIGHT HIP REVISION WAS PERFORMED ON (B)(6) 2006 DUE TO DISLOCATION. THE PATIENT'S OPERATIVE REPORT NOTED OLD BLOOD AND FLUID. THE CUP WAS REMOVED AND REPLACED WITH A TITANIUM CUP. ADDITIONAL INFORMATION PROVIDED IN PATIENT MEDICAL RECORDS INDICATES THE RIGHT HIP REVISION ON (B)(6) 2008 WAS DUE TO RECURRENT DISLOCATION. A REVIEW OF INVOICE HISTORY COULD NOT CONFIRM THE (B)(6) 2006 REVISION. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6)2006 AND A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. PATIENT'S LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, BONE/TISSUE DAMAGE, DIFFICULTY WALKING, DISLOCATION, ELEVATED METAL ION LEVELS AND METALLOSIS. SUBSEQUENTLY, PATIENT UNDERWENT RIGHT HIP REVISION PROCEDURES ON (B)(6) 2008 AND (B)(6) 2009. THE MODULAR HEAD WAS REMOVED AND REPLACED DURING THE (B)(6) 2008 REVISION PROCEDURE. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED IN THE (B)(6) 2009 REVISION PROCEDURE. THERE HAS BEEN NO REPORTED LEFT HIP REVISION PROCEDURE TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290515 M2A 1 PC SHELL 38MMX52MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 373650

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention